Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 10, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-00100 | |
Entity Registrant Name | THERAPEUTICSMD, INC. | |
Entity Central Index Key | 0000025743 | |
Entity Tax Identification Number | 87-0233535 | |
Entity Incorporation, State or Country Code | NV | |
Entity Address, Address Line One | 951 Yamato Road | |
Entity Address, Address Line Two | Suite 220 | |
Entity Address, City or Town | Boca Raton | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 33431 | |
City Area Code | 561 | |
Local Phone Number | 961-1900 | |
Title of 12(b) Security | Common Stock, par value $0.001 per share | |
Trading Symbol | TXMD | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 8,668,558 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash | $ 30,384 | $ 65,122 |
Accounts receivable, net of allowance for credit losses of $1,334 as of March 31, 2022 and December 31, 2021 | 35,413 | 36,176 |
Inventory | 8,967 | 7,622 |
Prepaid and other current assets | 9,660 | 10,548 |
Total current assets | 84,424 | 119,468 |
Fixed assets, net | 1,082 | 1,199 |
License rights and other intangible assets, net | 39,547 | 40,318 |
Right of use assets | 8,075 | 8,234 |
Other non-current assets | 253 | 253 |
Total assets | 133,381 | 169,472 |
Current liabilities: | ||
Current maturities of debt | 202,857 | 188,269 |
Accounts payable | 20,753 | 20,318 |
Accrued expenses and other current liabilities | 41,225 | 44,304 |
Total current liabilities | 264,835 | 252,891 |
Operating lease liabilities | 7,897 | 8,063 |
Other non-current liabilities | 1,229 | 2,139 |
Total liabilities | 273,961 | 263,093 |
Commitments and contingencies (Note 9) | ||
Stockholders' deficit: | ||
Preferred stock, par value $0.001; 10,000 shares authorized, none issued | 0 | 0 |
Common stock, par value $0.001; 12,000 shares authorized, 8,669 and 8,598 (each) adjusted for the 50-for-1 reverse stock split) issued and outstanding as of March 31, 2022 and December 31, 2021, respectively | 9 | 9 |
Additional paid-in capital | 959,792 | 957,730 |
Accumulated deficit | (1,100,381) | (1,051,360) |
Total stockholders' deficit | (140,580) | (93,621) |
Total liabilities and stockholders' deficit | $ 133,381 | $ 169,472 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)$ / sharesshares | Dec. 31, 2021USD ($)$ / sharesshares | |
Statement Of Financial Position [Abstract] | ||
Accounts Receivable, Allowance for Credit Loss | $ | $ 1,334 | $ 1,334 |
Preferred Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 |
Preferred Stock, Shares Authorized | 10,000,000 | 10,000,000 |
Preferred Stock, Shares Issued | 0 | 0 |
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 12,000,000 | 12,000,000 |
Common Stock, Shares, Issued | 8,669,000 | 8,598,000 |
Common Stock, Shares, Outstanding | 8,669,000 | 8,598,000 |
Reverse stock split, conversion ratio | 0.02 | |
Reverse stock split, description | 50-for-1 reverse stock split |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Total revenue, net | $ 19,333,000 | $ 19,866,000 |
Cost of goods sold | 4,860,000 | 4,687,000 |
Total gross profit | 14,473,000 | 15,179,000 |
Operating expenses: | ||
Selling and marketing | 18,895,000 | 24,024,000 |
General and administrative | 20,407,000 | 18,383,000 |
Research and development | 1,400,000 | 2,050,000 |
Total operating expenses | 40,702,000 | 44,457,000 |
Loss from operations | (26,229,000) | (29,278,000) |
Other expense: | ||
Loss on extinguishment of debt | (8,380,000) | |
Interest expense and other financing costs | (14,412,000) | (10,227,000) |
Other income, net | 122,000 | |
Total other expense, net | (22,792,000) | (10,105,000) |
Loss before income taxes | (49,021,000) | (39,383,000) |
Provision for income taxes | 0 | 0 |
Net loss | $ (49,021,000) | $ (39,383,000) |
Loss per common share, basic and diluted | $ (5.69) | $ (5.67) |
Weighted average common shares, basic and diluted | 8,614 | 6,945 |
Comprehensive loss: | ||
Net loss | $ (49,021,000) | $ (39,383,000) |
Comprehensive loss | (49,021,000) | (39,383,000) |
Product [Member] | ||
Total revenue, net | 18,914,000 | 19,632,000 |
License and Service [Member] | ||
Total revenue, net | $ 419,000 | $ 234,000 |
CONSOLIDATED STATEMENTS OF STOC
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' DEFICIT - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] |
Beginning balance, value at Dec. 31, 2020 | $ (124,001) | $ 6 | $ 754,938 | $ (878,945) |
Beginning balance, shares at Dec. 31, 2020 | 5,996,000 | |||
Shares issued for sale of common stock, net of cost | 150,899 | $ 2 | 150,897 | |
Shares issued for sale of common stock, net of cost, shares | 1,857,000 | |||
Shares issued for exercise of warrants and options, net of cashless exercises | 50 | 50 | ||
Shares issued for exercise of warrants and options, net of cashless exercises (in shares) | 10,000 | |||
Shares issued for vested restricted stock units (in shares) | 1,000 | |||
Share-based compensation | 2,957 | 2,957 | ||
Net loss | (39,383) | (39,383) | ||
Ending balance, value at Mar. 31, 2021 | (9,478) | $ 8 | 908,842 | (918,328) |
Ending balance, shares at Mar. 31, 2021 | 7,864,000 | |||
Beginning balance, value at Dec. 31, 2021 | $ (93,621) | $ 9 | 957,730 | (1,051,360) |
Beginning balance, shares at Dec. 31, 2021 | 8,598,000 | 8,598,000 | ||
Shares issued for vested restricted stock units (in shares) | 71,000 | |||
Share-based compensation | $ 2,062 | 2,062 | ||
Net loss | (49,021) | (49,021) | ||
Ending balance, value at Mar. 31, 2022 | $ (140,580) | $ 9 | $ 959,792 | $ (1,100,381) |
Ending balance, shares at Mar. 31, 2022 | 8,669,000 | 8,669,000 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (49,021) | $ (39,383) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,100 | 1,019 |
Charges to provision for doubtful accounts | 274 | 230 |
Inventory charge | 73 | 502 |
Debt financing fees | 9,048 | 1,272 |
Loss on extinguishment of debt | 8,380 | |
Share-based compensation | 2,062 | 2,957 |
Other | (7) | 216 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 489 | (1,567) |
Inventory | (1,418) | 145 |
Prepaid and other current assets | 888 | (817) |
Accounts payable | 435 | (10,758) |
Accrued expenses and other current liabilities | (1,829) | 7,804 |
Total adjustments | 19,495 | 1,003 |
Net cash used in operating activities | (29,526) | (38,380) |
Cash flows from investing activities: | ||
Payment of patent related costs | (170) | (375) |
Purchase of fixed assets | (42) | (63) |
Net cash used in investing activities | (212) | (438) |
Cash flows from financing activities: | ||
Proceeds from sale of common stock, net of costs | 150,899 | |
Proceeds from exercise of options and warrants | 50 | |
Repayments of debt | (5,000) | (50,000) |
Payment of debt financing fees | (5,000) | |
Net cash (used in) provided by financing activities | (5,000) | 95,949 |
Net (decrease) increase in cash | (34,738) | 57,131 |
Cash, beginning of period | 65,122 | 80,486 |
Cash, end of period | 30,384 | 137,617 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 5,364 | $ 8,955 |
Supplemental disclosure of noncash financing activities: | ||
Paid in kind ("PIK") debt financing fees with corresponding increase in debt | $ 30,000 |
Business, basis of presentation
Business, basis of presentation, new accounting standards and summary of significant accounting policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Business, basis of presentation, new accounting standards and summary of significant accounting policies | 1. Business, basis of presentation, new accounting standards and summary of significant accounting policies General TherapeuticsMD, Inc., a Nevada corporation (the “Company”) and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD ® ® ® ® ® ® ® TM SM We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. vitaCare Divestiture On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received a cash payment of $150.0 million, subject to adjustment as provided in the stock purchase agreement (the “ The Purchase Agreement contains customary representations and warranties, covenants and indemnities of the parties thereto. In addition, upon closing of the vitaCare divestiture, (i) we entered into a long-term services agreement with vitaCare to continue utilization of the vitaCare platform with respect to our products, and (ii) we and vitaCare entered into a transition services agreement for us to provide certain transition services to vitaCare for up to 12 months following the closing. Under the long-term services agreement, we are required to pay to vitaCare a minimum service fee for each respective annual contract year. Our estimated minimum service fee commitments for vitaCare are as follows: $5.2 million for the period from April 15, 2022 to December 31, 2022, $10.7 million for 2023, $13.4 million for 2024, $15.4 million for 2025, $16.2 million for 2026, and $5.5 million for the period from January 1, 2027 to April 14, 2027. COVID-19 With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. The ultimate global recovery from the pandemic will be dependent on, among other things, actions taken by governments and businesses to contain and combat the virus, including any variant strains, the speed and effectiveness of vaccine production and global distribution, as well as how quickly, and to what extent, normal economic and operating conditions can resume on a sustainable basis globally. Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses and implemented cost saving measures, which included negotiating lower fees or suspending services from third-party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses. In addition, we implemented a significant cost savings initiative that wa s designed to reduce our annual operating costs in 2022 , and we reduced the operating costs of the vitaCare business with the completion of the vitaCare Divestiture on April 14, 2022 . See above for additional information regarding the vitaCare Divestiture. The full impact of the COVID-19 pandemic continues to evolve. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate many of the negative effects of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which remain uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. Going concern We incurred a net loss of $49.0 million during the three months ended March 31, 2022, and as of that date, our current liabilities exceeded our current assets by $180.4 million and our total liabilities exceeded our total assets by $140.6 million. We will need to raise additional capital to repay the entire principal balance of the Financing Agreement, dated as of April 24, 2019, as amended (the “Financing Agreement”), with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent” or “Sixth Street”), various lenders from time to time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors, which matures on June 1, 2022, and to provide additional liquidity to fund our losses until our operations become cash flow positive. To address our capital needs, we are pursuing various equity and debt financing and other alternatives, including, but not limited to, the sale of vitaCare which was completed on April 14, 2022. The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock and the potential delisting of our common stock from the Nasdaq Global Select Market, and our available authorized shares. To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us. Along with considering additional financings, we have reviewed numerous potential scenarios in connection with steps that we may take to reduce our operating expenses. If we are unsuccessful with future financings and if the successful commercialization of ANNOVERA, IMVEXXY, or BIJUVA is delayed, or the continued impact of the COVID-19 pandemic or issues in our supply chains related to our third-party contract manufacturers on our business is worse than we anticipate, our existing cash reserves would be insufficient to repay the entire principal balance of the Financing Agreement or satisfy our liquidity needs. See Note 3, Inventory for additional information regarding risks associated with our contract manufacturers, particularly for ANNOVERA. The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. Common stock r everse stock split On May 6, 2022, we completed a reverse stock split of our common stock. As a result, shares of our common stock outstanding was split at a ratio of 50-for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of common stock. The number of authorized shares of common stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split. Additionally, all rights to receive shares of common stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the reverse stock split. Furthermore, remaining shares of common stock available for future issuance under share-based payment award plans and employee stock purchase plan were adjusted to give effect of the reverse stock split. Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors to effectuate the Reverse Stock Split. In this 10-Q Report, all historical number of shares of common stock and per share data have been adjusted to give effect to the Reverse Stock Split. Additionally, since the common stock par value was unchanged, historical amounts for common stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split. A. Basis of presentation We prepared the consolidated financial statements included in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our 2021 Annual Report on Form 10-K ("2021 10-K Report"). Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2021 10-K Report. Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts B. New accounting standards Adoption of new accounting standards New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on the Company’s consolidated financial statements or processes. Accounting standards issued but not yet adopted Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting and Scope. In March 2020 and January 2021, Accounting Standards Update (“ASU”) 2020-04 and ASU 2021-01 were issued, respectively. These ASUs provide optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR). These ASUs include practical expedients for contract modifications due to reference rate reform. Generally, contract modifications related to reference rate reform may be considered an event that does not require remeasurement or reassessment of a previous accounting determination at the modification date. These ASUs were effective upon issuance and may be applied prospectively to contract modifications made or evaluated on or before December 31, 2022. Our debt agreements currently include the use of alternate rates when LIBOR is not available. We do not expect the change from LIBOR to an alternate rate will have a material impact to our financial statements and, to the extent we enter into modifications of agreements that are impacted by the LIBOR phase-out, we will apply such guidance to those contract modifications. Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on the Company’s consolidated financial statements or processes. C. Estimates and assumptions The preparation of consolidated financial statements in conformity to U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimated assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions. D. Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 1, Business, basis of presentation, new accounting standards and summary of significant accounting policies of the accompanying notes to the consolidated financial statements included in our 2021 10-K Report, and in the section below. |
Accounts receivable
Accounts receivable | 3 Months Ended |
Mar. 31, 2022 | |
Receivables [Abstract] | |
Accounts receivable | 2. Accounts receivable The following sets forth activities in our allowance for credit losses (in thousands): Balance as of January 1, 2022 $ 1,334 Charges to provision for credit losses 274 Write-off of uncollectible receivables (274 ) Balance as of March 31, 2022 $ 1,334 |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | 3. Inventory Our inventory consisted of the following (in thousands): March 31, 2022 December 31, 2021 Raw materials $ 4,394 $ 3,042 Work in process 1,231 1,642 Finished products 3,342 2,938 Inventory $ 8,967 $ 7,622 We recorded inventory charges of $0.1 million and $0.5 million for the three months ended March 31, 2022 and 2021, respectively. We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA. We do not have a long-term supply agreement for the manufacture of our prescription vitamins. Additionally, we do not have long-term contracts for the supply of all the active pharmaceutical ingredients (“API”) used in ANNOVERA and BIJUVA. One of our third-party contract manufacturers that manufactures ANNOVERA has recently experienced an increase in difficulties with manufacturing of ANNOVERA, which has resulted in intermittent supply interruptions of ANNOVERA for commercial distribution. The challenges are multifactorial and include variability in raw material supply and normal manufacturing variation due to a semi-manual process. This has recently resulted in challenges to supply ANNOVERA at a rate that meets the projected demand for ANNOVERA. To mitigate the manufacturing challenges, in August 2021, we filed a supplemental New Drug Application (“NDA”) with the FDA to modify the testing specifications for ANNOVERA to allow increased consistency of supply of ANNOVERA. In December 2021, FDA determined that it could not approve the supplemental NDA without additional information. In its complete response letter (“CRL”), the FDA provided recommendations and requested additional information that could support approval of revisions to certain testing specifications. In January 2022, we responded to the CRL, and provided additional information to the FDA and modified the request to revise the manufacturing testing limits based on the FDA feedback. We expect a response from the FDA by the end of second quarter of 2022. We have continued to manufacture and supply ANNOVERA under the existing specifications as well as (i) ramping up manufacturing sufficient to better meet second quarter of 2022 demands notwithstanding existing challenges, (ii) added resources to increase production volumes, (iii) increasing yield per manufacturing batch, and (iv) increasing production capacity to better meet product demands to realize revenue potential, including reducing dependency on labor resources, increasing efficiency in manufacturing and testing, and automating some of the processes. In the meantime, our third-party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market, which would have an adverse effect on our business, results of operations and financial condition. Additionally, we may incur increased write-offs of ANNOVERA products manufactured in 2022 that do not meet existing specifications. We have also experienced a greater than expected amount of raw materials for ANNOVERA being out of specification. If any of our third-party contract manufacturers or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, or if the manufacturing specification modifications that we have requested are not approved by the FDA, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position. |
Prepaid and other current asset
Prepaid and other current assets | 3 Months Ended |
Mar. 31, 2022 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Prepaid and other current assets | 4 . Prepaid and other current assets Our prepaid and other current assets consisted of the following (in thousands): March 31, 2022 December 31, 2021 Insurance $ 1,644 $ 2,731 Paragraph IV legal proceeding costs 2,304 2,304 Other 5,712 5,513 Prepaid and other current assets $ 9,660 $ 10,548 |
Fixed assets
Fixed assets | 3 Months Ended |
Mar. 31, 2022 | |
Property Plant And Equipment [Abstract] | |
Fixed assets | 5 . Fixed assets Our fixed assets, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Furniture and fixtures $ 1,407 $ 1,407 Computer and office equipment 1,897 1,855 Computer software 375 375 Leasehold improvements 80 80 Fixed assets 3,759 3,717 Less: accumulated depreciation and amortization 2,677 2,518 Fixed assets, net $ 1,082 $ 1,199 We recorded depreciation expense of $0.2 million for the three months ended March 31, 2022 and 2021. |
Licensed rights and other intan
Licensed rights and other intangible assets | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Licensed rights and other intangible assets | 6 . Licensed rights and other intangible assets The following provides information about our license rights and other intangible assets, net (in thousands): March 31, 2022 December 31, 2021 Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Net Amount Amortization Net Licensed rights and intangible assets subject to amortization: License rights $ 40,000 $ 7,580 $ 32,420 $ 40,000 $ 6,826 $ 33,174 Hormone therapy drug patents 6,117 1,229 4,888 5,834 1,042 4,792 Hormone therapy drug patents applied and pending approval 1,907 — 1,907 2,020 — 2,020 License rights and other intangible assets subject to amortization 48,024 8,809 39,215 47,854 7,868 39,986 Intangible assets not subject to amortization: Trademarks/trade name rights 332 — 332 332 — 332 License rights and other intangible assets, net $ 48,356 $ 8,809 $ 39,547 $ 48,186 $ 7,868 $ 40,318 We recorded amortization expense related to the exclusive license rights agreement with Population Council of $0.8 million for the three months ended March 31, 2022 and 2021. We recorded amortization expense related to patents of $0.2 million and $0.1 million for the three months ended March 31, 2022 and 2021, respectively. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables And Accruals [Abstract] | |
Accrued expenses and other current liabilities | 7 . Accrued expenses and other current liabilities Other accrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2022 December 31, 2021 Payroll and related costs $ 10,845 $ 13,764 Rebates 9,810 11,010 Sales returns and coupons 1,252 2,422 Selling and marketing 2,611 2,850 Research and development expenses 2,295 1,995 Wholesale distributor fees 6,352 3,614 Professional fees 2,080 2,571 Operating lease liabilities 1,369 1,361 Other accrued expenses and current liabilities 4,611 4,717 Accrued expenses and other current liabilities $ 41,225 $ 44,304 We expense advertising costs when incurred, which amounted to $1.9 million and $6.2 million for the three months ended March 31, 2022 and 2021, respectively. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 8 . Debt Our debt consisted of the following (in thousands): March 31, 2022 December 31, 2021 Financing Agreement $ 225,000 $ 200,000 Less: deferred financing fees 22,143 11,731 Debt, net $ 202,857 $ 188,269 Financing agreement In March 2022, we entered into Amendment No. 9 to the Financing Agreement (“Amendment No. 9”) vitaCare vitaCare Amendment No. 9 was accounted for as an extinguishment of debt modification in accordance with U.S. GAAP. Accordingly, in March 2022, we recorded an $8.4 million loss on extinguishment of debt, which represented the unamortized deferred financing fees, net of previously accrued prepayment fees. Additionally, we made a paid in kind (“PIK”) amendment financing fee of $30.0 million, which was added to the principal balance of the Financing Agreement As of March 31, 2022, our unamortized deferred financing fees was $22.1 million. O n April 14, 2022, we utilized $120.0 million of net proceeds from the vitaCare Divestiture to pay as prepayment on our debt under the terms of Amendment No. 9. Additionally, with the prepayment on the debt, $16.0 million of the n accordance with Amendment No. 9 Debt covenants The Financing Agreement contains customary restrictions and covenants applicable to us that are customary for financings of this type. Among other requirements, we are required to maintain a minimum unrestricted cash balance. Beginning on February 7, 2022 to March 8, 2022, we did not maintain the required unrestricted cash balance of $60.0 million. In connection with Amendment No. 9, the lenders waived this event of default and reduced the required minimum unrestricted cash balance. the minimum unrestricted cash balance covenant, as per Amendment No.9, will be $ 10.0 million minus specified payables, which will fluctuate based on our accounts payable balance. Interest and financing costs Interest expense and other financing costs consisted of the following (in thousands): Three Months Ended March 31, 2022 2021 Interest expense $ 5,364 $ 6,455 Interest prepayment fees — 2,500 Financing fees amortization 9,048 1,272 Interest expense and other financing costs $ 14,412 $ 10,227 |
Commitments and contingencies
Commitments and contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and contingencies | 9 . Commitments and contingencies Minimum purchase commitments We have manufacturing and supply agreements whereby we are required to purchase from Catalent, Inc. (“Catalent”) a minimum number of units of BIJUVA and IMVEXXY softgels during each respective annual contract year. The annual contract period for BIJUVA and IMVEXXY ends each April and July, respectively. If the minimum order quantities of BIJUVA or IMVEXXY are not met, we are required to pay a minimum commitment fee equal to 50% or 60%, respectively, of the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of BIJUVA or IMVEXXY during each product’s respective contract year. Additionally, with another third-party manufacturer, we have a manufacturing and supply agreement, renewable annually, whereby we are required to purchase a minimum number of units of ANNOVERA during a contract year. The annual contract period for ANNOVERA ends each August. If the minimum order quantities of ANNOVERA are not met, we are required to pay a minimum commitment fee equal to the difference between the total amount we would have paid if the minimum requirement had been fulfilled and the total amount of purchases of ANNOVERA during the contract year. For each of the three annual contract years ending in 2021, we have met our minimum purchase number of units in all material respects. For annual contract years ending in 2022 and thereafter, we will continue to evaluate whether we will be able to meet each annual contract year’s respective minimum purchase commitment and will record a liability for estimated minimum commitment fees if we believe that we will not be able to reasonably meet the minimum purchase commitment. We believe that minimum commitment fees that we may pay, if any, will not have a material impact to our financial position and operating results. Legal proceedings In February 2020, we received a Paragraph IV certification notice letter (the “IMVEXXY Notice Letter”) regarding an Abbreviated New Drug Application (“ANDA”) submitted to FDA by Teva Pharmaceuticals USA, Inc. (“Teva”). The ANDA seeks approval from FDA to commercially manufacture, use, or sell a generic version of the 4 mcg and 10 mcg doses of IMVEXXY. In the IMVEXXY Notice Letter, Teva alleges that TherapeuticsMD patents listed in FDA’s Orange Book that claim compositions and methods of IMVEXXY (the “IMVEXXY Patents”) are invalid, unenforceable, and/or will not be infringed by Teva’s commercial manufacture, use, or sale of its proposed generic drug product. The IMVEXXY Patents identified in the IMVEXXY Notice Letter expire in 2032 or 2033. In April 2020, we filed a complaint for patent infringement against Teva in the United States District Court for the District of New Jersey arising from Teva’s ANDA filing with the FDA. We are seeking, among other relief, an order that the effective date of any FDA approval of Teva’s ANDA would be a date no earlier than the expiration of the IMVEXXY Patents and equitable relief enjoining Teva from infringing the IMVEXXY Patents. Teva has filed its answer and counterclaim to the complaint, alleging that the IMVEXXY Patents are invalid and not infringed. In July 2021, following a proposal by Teva, the District Court entered an order temporarily staying all proceedings in the IMVEXXY litigation, which order was filed under seal. In September 2021, the District Court made available a public version of the order following the parties’ agreement to a consent motion to redact information Teva contended was confidential. The order provides that the statutory stay that prevents FDA from granting final approval of the ANDA for 30 months from the date of the Notice Letter will be extended for the number of days that the stay of the IMVEXXY litigation is in place. The length of the stay of the IMVEXXY litigation is dependent on further action by Teva. As of March 31, 2022, for the IMVEXXY Paragraph IV legal proceeding, we have incurred and recorded legal costs amounting to $2.3 million in prepaid expenses and other current assets since we believe that we will successfully prevail in this legal proceeding. Upon the successful conclusion of the legal proceeding, the related capitalized legal costs will be reclassified to patents, in license rights and other intangible assets, net, in the accompanying consolidated balance sheets, and such costs will be amortized over the remaining useful life of the patents. If we are unsuccessful in this legal proceeding, then the related capitalized legal costs for this legal preceding and any unamortized IMVEXXY patent costs that were previously capitalized will be immediately expensed in the period in which we become aware of an unsuccessful legal proceeding. From time to time, we are involved in other litigations and proceedings in the ordinary course of business. We are currently not involved in any other litigations and proceedings that we believe would have a material effect on our consolidated financial condition, results of operations, or cash flows. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity (Deficit) | 1 0 . Stockholders’ equity (deficit) Warrants The following tables summarizes the status of our outstanding and exercisable warrants and related transactions (each adjusted to account for the 50-for-1 Outstanding and exercisable Warrants Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 103 $ 76.19 $ - 8.3 Exercised - - As of March 31, 2022 103 $ 76.19 $ - 8.1 Share-based compensation payment plans As of March 31, 2022, 831,066 shares of common stock were subject to outstanding awards under our share-based payment award plans and inducement grants (calculated using the base number of PSUs that may vest). If we assume the maximum achievement of performance goals for PSUs, then 963,584 outstanding awards under our share-based payment award plans and inducement grants. As of March 31, 2022, 83,880 shares of common stock were available for future grants of share-based payment awards under the TherapeuticsMD, Inc. 2019 Stock Incentive Plan. The following table summarizes the status of our outstanding and exercisable options and related transactions 50-for-1 since December 31, 2021 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Outstanding Exercisable Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 353 $ 225.97 $ - 3.8 336 $ 230.93 $ - 3.6 Cancelled/Forfeited (37 ) 161.72 Expired - 175.77 As of March 31, 2022 316 $ 231.87 $ - 3.7 300 $ 237.58 $ - 3.6 The following table summarizes the status of our RSUs and related transactions (each adjusted to account for the 50-for-1 Outstanding Vested and not settled RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of January 1, 2022 272 $ 58.17 $ 4,890 31 $ 105.28 $ 566 Granted 106 21.70 Vested and settled (32 ) 105.28 469 Cancelled/Forfeited (7 ) 53.74 As of March 31, 2022 339 $ 43.11 $ 6,440 13 $ 74.17 $ 252 The following table summarizes the status of our PSU and related transactions (each adjusted to account for the 50-for-1 Outstanding Vested and not settled PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of January 1, 2022 164 $ 51.50 $ 2,953 39 $ 58.81 $ 709 Granted 63 19.00 Vested and settled (39 ) 58.81 571 Cancelled/Forfeited (12 ) 57.69 As of March 31, 2022 176 (1) $ 37.85 $ 3,346 - $ - $ - (1) depending on the Company’s achievement of certain performance goals Share-based payment compensation cost Share-based payment compensation expense for PSUs is based on our current assessment of the most likely probability of the Company’s achievement of certain performance goals. F or the three months ended March 31, 2022 and 2021, we recorded share-based payment compensation costs of $2.1 million and $3.0 million, respectively, in connection with previously granted options, RSU and PSUs, and shares of common stock issuable under the ESPP. As of March 31, 2022, we had $17.8 million of unrecognized share-based payment award compensation cost related to unvested options, RSUs and PSUs as well as shares issuable under the ESPP, which may be adjusted if certain performance targets are achieved and for future changes in forfeitures and is included as additional paid-in capital in the accompanying consolidated balance sheets. No tax benefit was realized due to a continued pattern of net losses. The unrecognized compensation cost as of March 31, 2022 is expected to be recognized as share-based payment award compensation over a weighted average period of 2.2 years as follows (in thousands): Year Ending December 31, 2022 (9 months) $ 8,124 2023 5,838 2024 3,513 2025 368 $ 17,843 |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2022 | |
Disaggregation Of Revenue [Abstract] | |
Revenue | 1 1 . Revenue The following table provides information about disaggregated revenue by product mix and service (in thousands): Three Months Ended March 31, 2022 2021 Product revenue: ANNOVERA $ 8,510 $ 8,750 IMVEXXY 6,969 7,012 BIJUVA 2,560 2,445 Prescription vitamin 875 1,425 Product revenue, net 18,914 19,632 License and service 419 234 Total revenue, net $ 19,333 $ 19,866 We have entered into a license and supply agreement (the “Knight License Agreement”), with Knight Therapeutics, Inc. (“Knight”) pursuant to which we granted Knight an exclusive license to commercialize IMVEXXY and BIJUVA in Canada and Israel. We also have entered into a licensing and supply agreement (the “Theramex License Agreement”) with Theramex HQ UK Limited (“Theramex”) pursuant to which we granted Theramex an exclusive license to commercialize IMVEXXY and BIJUVA for human use outside of the U.S., except for Canada and Israel. BIJUVA sales through the Theramex License Agreement started in the third quarter of 2021, and we recorded BIJUVA sales of $0.7 million for the three months ended March 31, 2022. As of March 31, 2022, no BIJUVA sales have been made through the Knight License Agreement, and no IMVEXXY sales have been made through either of the licensing agreements. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 1 2 . Income taxes We do not expect to pay any significant federal or state income taxes as a result of (i) the losses recorded during the three months ended March 31, 2022 and 2021, (ii) additional losses expected for the remainder of 2022 or losses recorded in 2021, or (iii) net operating losses carry forwards from prior years. We recorded a full valuation allowance of the net operating losses for the three months ended March 31, 2022 and 2021. Accordingly, there were no provisions for income taxes for the three months ended March 31, 2022 and 2021. Additionally, as of March 31, 2022 and December 31, 2021, we maintain a full valuation allowance for all deferred tax assets. |
Loss per common share
Loss per common share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Loss per common share | 1 3 . Loss per common share The following table sets forth the computation of basic and diluted loss per common share (each adjusted to account for the 50 Three Months Ended March 31, 2022 2021 Numerator: Net loss $ (49,021 ) $ (39,383 ) Denominator: Weighted average common shares for basic loss per common share 8,614 6,945 Effect of dilutive securities — — Weighted average common shares for diluted loss per common share 8,614 6,945 Loss per common share, basic and diluted $ (5.69 ) $ (5.67 ) Since we reported a net loss for the three months ended March 31, 2022 and 2021, our potentially dilutive securities are deemed to be anti-dilutive, accordingly, there was no effect of dilutive securities. Therefore, our basic and diluted loss per common share and our basic and diluted weighted average common share are the same for the three months ended March 31, 2022 and 2021. The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during the respective three months ended March 31, 2022 and 2021 (in thousands): As of March 31, 2022 2021 Stock options 316 475 RSUs 339 147 PSUs 176 48 Warrants 103 118 934 788 |
Related parties
Related parties | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related Parties | 1 4 . Related parties A former member of our Board, J. Martin Carroll, who resigned in December 2021, is a member of Catalent’s Board. Accordingly, Catalent ceased to be a related a party to the Company in December 2021. From time to time, we have entered into agreements with Catalent and its affiliates in the normal course of business. From July 2015 to December 2021, agreements with Catalent have been reviewed by independent directors of our Company, or a committee consisting of independent directors of our Company. For manufacturing activities, Catalent billed us $0.8 million for the three months ended March 31, 2021. In addition, we have minimum purchase requirements in place with Catalent as disclosed in Note 9, Commitments and contingencies. A member of our Board, |
Business concentrations
Business concentrations | 3 Months Ended |
Mar. 31, 2022 | |
Risks And Uncertainties [Abstract] | |
Business concentrations | 1 5 . Business concentrations We sell our products to wholesale distributors, specialty pharmacies, specialty distributors, and chain drug stores that generally sell products to retail pharmacies, hospitals, and other institutional customers. Customers with product revenue equal to or greater than 10% Three Months Ended March 31, 2022 2021 Customer A 11% 13% Customer B 18% 18% Customer C 17% 22% Customer F 14% * * Less than 10% of total product revenue Customers that accounted for 10% March 31, 2022 December 31, 2021 Customer B 21% 21% Customer C 34% 35% Customer D * 11% Customer F 16% * * Balance was less than 10% of accounts receivable, gross We rely on third parties for the manufacture and supply of our products, as well as third-party logistics providers. In instances where these parties fail to perform their obligations, we may be unable to find alternatives suppliers or satisfactorily deliver our products to our customers on time, if at all. Vendors with product purchases equal to or greater than 10% Three Months Ended March 31, 2022 2021 Catalent 28% 29% Vendor A 39% 33% Vendor B 27% 32% * Less than 10% of total product purchases Vendors that accounted for 10% March 31, 2022 December 31, 2021 Vendor E 30% 19% Vendor F 10% 20% * Balance was less than 10% of total accounts payable |
Business, basis of presentati_2
Business, basis of presentation, new accounting standards and summary of significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
General | General TherapeuticsMD, Inc., a Nevada corporation (the “Company”) and its consolidated subsidiaries are referred to collectively in this Quarterly Report on Form 10-Q (“10-Q Report”) as “TherapeuticsMD,” “we,” “our” and “us.” This 10-Q Report includes our trademarks, trade names and service marks, such as TherapeuticsMD ® ® ® ® ® ® ® TM SM We are a women’s healthcare company with a mission of creating and commercializing innovative products to support the lifespan of women from pregnancy prevention through menopause. At TherapeuticsMD, we combine entrepreneurial spirit, clinical expertise, and business leadership to develop and commercialize health solutions that enable new standards of care for women. Our solutions range from a patient-controlled, long-lasting contraceptive to advanced hormone therapy pharmaceutical products. We also have a portfolio of branded and generic prescription prenatal vitamins under the vitaMedMD and BocaGreenMD brands. Our portfolio of products focused on women’s health allows us to efficiently leverage our sales and marketing plan to grow our recently approved products. |
vitaCare Divestiture | vitaCare Divestiture On April 14, 2022, we completed the divestiture of vitaCare Prescription Services, Inc. (“vitaCare”) with the sale of all of vitaCare’s issued and outstanding capital stock (the “vitaCare Divestiture”). We received a cash payment of $150.0 million, subject to adjustment as provided in the stock purchase agreement (the “ The Purchase Agreement contains customary representations and warranties, covenants and indemnities of the parties thereto. In addition, upon closing of the vitaCare divestiture, (i) we entered into a long-term services agreement with vitaCare to continue utilization of the vitaCare platform with respect to our products, and (ii) we and vitaCare entered into a transition services agreement for us to provide certain transition services to vitaCare for up to 12 months following the closing. Under the long-term services agreement, we are required to pay to vitaCare a minimum service fee for each respective annual contract year. Our estimated minimum service fee commitments for vitaCare are as follows: $5.2 million for the period from April 15, 2022 to December 31, 2022, $10.7 million for 2023, $13.4 million for 2024, $15.4 million for 2025, $16.2 million for 2026, and $5.5 million for the period from January 1, 2027 to April 14, 2027. |
COVID-19 | COVID-19 With multiple variant strains of the SARS-Cov-2 virus and the COVID-19 disease that it causes (collectively, “COVID-19”) still circulating, we continue to be subject to risks and uncertainties in connection with the COVID-19 pandemic. The extent of the future impact of the COVID-19 pandemic on our business continues to be highly uncertain and difficult to predict. The ultimate global recovery from the pandemic will be dependent on, among other things, actions taken by governments and businesses to contain and combat the virus, including any variant strains, the speed and effectiveness of vaccine production and global distribution, as well as how quickly, and to what extent, normal economic and operating conditions can resume on a sustainable basis globally. Since the early phase of the COVID-19 pandemic, we have been using substantial virtual options to ensure business continuity. We have also partnered with independent community pharmacies and multiple third-party online pharmacies and telemedicine providers that focus on contraception or menopause which provide patients real-time access to both diagnosis and treatment. We continue to support prescribers’ needs with samples and product materials through our sales force. If access is restricted, we have mailing options in place for these materials. We also have business continuity plans and infrastructure in place that allows for live virtual e-detailing of our products. As part of our response to the COVID-19 pandemic, we implemented measures to reduce marketing expenses and implemented cost saving measures, which included negotiating lower fees or suspending services from third-party vendors; implementing a company-wide hiring restriction; delaying or cancelling non-critical information technology projects; and eliminating non-essential travel, entertainment, meeting, and event expenses. In addition, we implemented a significant cost savings initiative that wa s designed to reduce our annual operating costs in 2022 , and we reduced the operating costs of the vitaCare business with the completion of the vitaCare Divestiture on April 14, 2022 . See above for additional information regarding the vitaCare Divestiture. The full impact of the COVID-19 pandemic continues to evolve. As of the date of issuance of these consolidated financial statements, the future extent to which the COVID-19 pandemic may continue to materially impact our financial condition, liquidity, or results of operations remains uncertain. We are continuing to assess the effect of the COVID-19 pandemic on our operations by monitoring the spread of COVID-19 and the various actions implemented to combat the pandemic throughout the world. Even after the COVID-19 pandemic has subsided, we may continue to experience adverse impacts to our business as a result of any economic recession or depression that has occurred or may occur in the future. While we currently believe that our COVID-19 contingency plan has the ability to mitigate many of the negative effects of the COVID-19 pandemic on our business, the severity of the impact of the COVID-19 pandemic on our business will depend on a number of factors, including, but not limited to, the duration and severity of the pandemic, the duration of “social distancing” orders, the ability of our sales force to access healthcare providers to promote our products, increases in unemployment, which could reduce access to commercial health insurance for our patients, thus limiting payer coverage for our products, and the impact of the pandemic on our global supply chain, all of which remain uncertain. Our future results of operations and liquidity could be materially adversely affected by delays in payments of outstanding receivable amounts beyond normal payment terms, supply chain disruptions, uncertain demand, and the impact of any initiatives or programs that we may undertake to address financial and operations challenges that we may face. |
Going concern | Going concern We incurred a net loss of $49.0 million during the three months ended March 31, 2022, and as of that date, our current liabilities exceeded our current assets by $180.4 million and our total liabilities exceeded our total assets by $140.6 million. We will need to raise additional capital to repay the entire principal balance of the Financing Agreement, dated as of April 24, 2019, as amended (the “Financing Agreement”), with Sixth Street Specialty Lending, Inc., as administrative agent (the “Administrative Agent” or “Sixth Street”), various lenders from time to time party thereto, and certain of our subsidiaries party thereto from time to time as guarantors, which matures on June 1, 2022, and to provide additional liquidity to fund our losses until our operations become cash flow positive. To address our capital needs, we are pursuing various equity and debt financing and other alternatives, including, but not limited to, the sale of vitaCare which was completed on April 14, 2022. The equity financing alternatives may include the private placement of equity, equity-linked, or other similar instruments or obligations with one or more investors, lenders, or other institutional counterparties or an underwritten public equity or equity-linked securities offering. Our ability to sell equity securities may be limited by market conditions, including the market price of our common stock and the potential delisting of our common stock from the Nasdaq Global Select Market, and our available authorized shares. To the extent that we raise additional capital through the sale of such securities, the ownership interests of our existing stockholders will be diluted, and the terms of these new securities may include liquidation or other preferences that adversely affect the rights of our existing stockholders. If we are not successful in obtaining additional financing, we could be forced to discontinue or curtail our business operations, sell assets at unfavorable prices, or merge, consolidate, or combine with a company with greater financial resources in a transaction that might be unfavorable to us. Along with considering additional financings, we have reviewed numerous potential scenarios in connection with steps that we may take to reduce our operating expenses. If we are unsuccessful with future financings and if the successful commercialization of ANNOVERA, IMVEXXY, or BIJUVA is delayed, or the continued impact of the COVID-19 pandemic or issues in our supply chains related to our third-party contract manufacturers on our business is worse than we anticipate, our existing cash reserves would be insufficient to repay the entire principal balance of the Financing Agreement or satisfy our liquidity needs. See Note 3, Inventory for additional information regarding risks associated with our contract manufacturers, particularly for ANNOVERA. The presence of these projected factors in conjunction with the uncertainty of the capital markets raises substantial doubt about the Company's ability to continue as a going concern for the next twelve months from the issuance of these financial statements. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. |
Basis of presentation | A. Basis of presentation We prepared the consolidated financial statements included in this 10-Q Report following the requirements of the United States (“U.S.”) Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain notes or other financial information that are normally required by accounting principles generally accepted in the U.S. (“U.S. GAAP”) for complete financial statements can be condensed or omitted. However, except as disclosed herein, there has been no material change in the information disclosed in the notes included in our 2021 Annual Report on Form 10-K ("2021 10-K Report"). Revenues, expenses, assets, liabilities, and equities can vary during each quarter of the year. Therefore, the results and trends in these interim financial statements may not be representative of those for the full year. In our opinion, all adjustments necessary for a fair statement of the financial statements, which are of a normal and recurring nature, have been made for the interim periods reported. The information included in this 10-Q Report should be read in conjunction with the consolidated financial statements and accompanying notes included in our 2021 10-K Report. Certain amounts in the consolidated financial statements and accompanying notes may not add due to rounding, and all percentages have been calculated using unrounded amounts |
Common stock reverse stock split | Common stock r everse stock split On May 6, 2022, we completed a reverse stock split of our common stock. As a result, shares of our common stock outstanding was split at a ratio of 50-for-1 (the “Reverse Stock Split”) with any fractional shares resulting from the Reserve Stock Split rounded up to the next whole share of common stock. The number of authorized shares of common stock was also correspondingly reduced from 600.0 million shares to 12.0 million shares to give effect to the Reverse Stock Split. Additionally, all rights to receive shares of common stock under outstanding warrants, options, restricted stock units (“RSUs”) and performance stock units (“PSUs”) were adjusted to give effect of the reverse stock split. Furthermore, remaining shares of common stock available for future issuance under share-based payment award plans and employee stock purchase plan were adjusted to give effect of the reverse stock split. Pursuant to Section 78.209 of the Nevada Revised Statutes, the approval of our stockholders was not required for our Board of Directors to effectuate the Reverse Stock Split. In this 10-Q Report, all historical number of shares of common stock and per share data have been adjusted to give effect to the Reverse Stock Split. Additionally, since the common stock par value was unchanged, historical amounts for common stock and additional paid-in capital have been adjusted to give effect to the Reverse Stock Split. |
New accounting standards | B. New accounting standards Adoption of new accounting standards New accounting standards or accounting standards updates were assessed and determined to be either not applicable or did not have a material impact on the Company’s consolidated financial statements or processes. Accounting standards issued but not yet adopted Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting and Scope. In March 2020 and January 2021, Accounting Standards Update (“ASU”) 2020-04 and ASU 2021-01 were issued, respectively. These ASUs provide optional guidance for a limited period of time to ease potential accounting impacts associated with transitioning away from reference rates that are expected to be discontinued, such as London Interbank Offered Rate (LIBOR). These ASUs include practical expedients for contract modifications due to reference rate reform. Generally, contract modifications related to reference rate reform may be considered an event that does not require remeasurement or reassessment of a previous accounting determination at the modification date. These ASUs were effective upon issuance and may be applied prospectively to contract modifications made or evaluated on or before December 31, 2022. Our debt agreements currently include the use of alternate rates when LIBOR is not available. We do not expect the change from LIBOR to an alternate rate will have a material impact to our financial statements and, to the extent we enter into modifications of agreements that are impacted by the LIBOR phase-out, we will apply such guidance to those contract modifications. Other recently issued accounting standards not yet adopted by us are not expected, upon adoption, to have a material impact on the Company’s consolidated financial statements or processes. |
Estimates and assumptions | C. Estimates and assumptions The preparation of consolidated financial statements in conformity to U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. We evaluate our estimated assumptions based on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ, at times in material amounts, from these estimates under different assumptions or conditions. |
Significant accounting policies | D. Significant accounting policies The significant accounting policies we use for quarterly financial reporting are disclosed in Note 1, Business, basis of presentation, new accounting standards and summary of significant accounting policies of the accompanying notes to the consolidated financial statements included in our 2021 10-K Report, and in the section below. |
Accounts receivable (Tables)
Accounts receivable (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Receivables [Abstract] | |
Summary of accounts receivable allowance for credit losses | The following sets forth activities in our allowance for credit losses (in thousands): Balance as of January 1, 2022 $ 1,334 Charges to provision for credit losses 274 Write-off of uncollectible receivables (274 ) Balance as of March 31, 2022 $ 1,334 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Summary of Inventory | Our inventory consisted of the following (in thousands): March 31, 2022 December 31, 2021 Raw materials $ 4,394 $ 3,042 Work in process 1,231 1,642 Finished products 3,342 2,938 Inventory $ 8,967 $ 7,622 |
Prepaid and other current ass_2
Prepaid and other current assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Prepaid Expense And Other Assets Current [Abstract] | |
Schedule of prepaid and other current assets | Our prepaid and other current assets consisted of the following (in thousands): March 31, 2022 December 31, 2021 Insurance $ 1,644 $ 2,731 Paragraph IV legal proceeding costs 2,304 2,304 Other 5,712 5,513 Prepaid and other current assets $ 9,660 $ 10,548 |
Fixed assets (Tables)
Fixed assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property Plant And Equipment [Abstract] | |
Summary of Fixed Assets, Net | Our fixed assets, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Furniture and fixtures $ 1,407 $ 1,407 Computer and office equipment 1,897 1,855 Computer software 375 375 Leasehold improvements 80 80 Fixed assets 3,759 3,717 Less: accumulated depreciation and amortization 2,677 2,518 Fixed assets, net $ 1,082 $ 1,199 |
Licensed rights and other int_2
Licensed rights and other intangible assets (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Summary of Information about License Rights and Other Intangible Assets, Net | The following provides information about our license rights and other intangible assets, net (in thousands): March 31, 2022 December 31, 2021 Gross Gross Carrying Accumulated Carrying Accumulated Amount Amortization Net Amount Amortization Net Licensed rights and intangible assets subject to amortization: License rights $ 40,000 $ 7,580 $ 32,420 $ 40,000 $ 6,826 $ 33,174 Hormone therapy drug patents 6,117 1,229 4,888 5,834 1,042 4,792 Hormone therapy drug patents applied and pending approval 1,907 — 1,907 2,020 — 2,020 License rights and other intangible assets subject to amortization 48,024 8,809 39,215 47,854 7,868 39,986 Intangible assets not subject to amortization: Trademarks/trade name rights 332 — 332 332 — 332 License rights and other intangible assets, net $ 48,356 $ 8,809 $ 39,547 $ 48,186 $ 7,868 $ 40,318 |
Accrued expenses and other cu_2
Accrued expenses and other current liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables And Accruals [Abstract] | |
Schedule of Other Accrued Expenses and Other Current Liabilities | Other accrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2022 December 31, 2021 Payroll and related costs $ 10,845 $ 13,764 Rebates 9,810 11,010 Sales returns and coupons 1,252 2,422 Selling and marketing 2,611 2,850 Research and development expenses 2,295 1,995 Wholesale distributor fees 6,352 3,614 Professional fees 2,080 2,571 Operating lease liabilities 1,369 1,361 Other accrued expenses and current liabilities 4,611 4,717 Accrued expenses and other current liabilities $ 41,225 $ 44,304 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Debt | Our debt consisted of the following (in thousands): March 31, 2022 December 31, 2021 Financing Agreement $ 225,000 $ 200,000 Less: deferred financing fees 22,143 11,731 Debt, net $ 202,857 $ 188,269 |
Summary of Interest Expense and Other Financing Costs | Interest expense and other financing costs consisted of the following (in thousands): Three Months Ended March 31, 2022 2021 Interest expense $ 5,364 $ 6,455 Interest prepayment fees — 2,500 Financing fees amortization 9,048 1,272 Interest expense and other financing costs $ 14,412 $ 10,227 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Summary of our Outstanding and Exercisable Warrants and Related Transactions | The following tables summarizes the status of our outstanding and exercisable warrants and related transactions (each adjusted to account for the 50-for-1 Outstanding and exercisable Warrants Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 103 $ 76.19 $ - 8.3 Exercised - - As of March 31, 2022 103 $ 76.19 $ - 8.1 |
Summary of Stock Option Activity | The following table summarizes the status of our outstanding and exercisable options and related transactions 50-for-1 since December 31, 2021 (in thousands, except weighed average exercise price and weighted average remaining contractual life data): Outstanding Exercisable Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) Options Awards Weighted Average Exercise Price Aggregate Intrinsic Value Weighted Average Remaining Contractual Life (in Years) As of January 1, 2022 353 $ 225.97 $ - 3.8 336 $ 230.93 $ - 3.6 Cancelled/Forfeited (37 ) 161.72 Expired - 175.77 As of March 31, 2022 316 $ 231.87 $ - 3.7 300 $ 237.58 $ - 3.6 |
Summary of Unrecognized Share Based Compensation Cost Expected to be Recognized | The unrecognized compensation cost as of March 31, 2022 is expected to be recognized as share-based payment award compensation over a weighted average period of 2.2 years as follows (in thousands): Year Ending December 31, 2022 (9 months) $ 8,124 2023 5,838 2024 3,513 2025 368 $ 17,843 |
Restricted Stock Units [Member] | |
Schedule of RSUs and PSUs | The following table summarizes the status of our RSUs and related transactions (each adjusted to account for the 50-for-1 Outstanding Vested and not settled RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value RSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of January 1, 2022 272 $ 58.17 $ 4,890 31 $ 105.28 $ 566 Granted 106 21.70 Vested and settled (32 ) 105.28 469 Cancelled/Forfeited (7 ) 53.74 As of March 31, 2022 339 $ 43.11 $ 6,440 13 $ 74.17 $ 252 |
Performance Shares Unit [Member] | |
Schedule of RSUs and PSUs | The following table summarizes the status of our PSU and related transactions (each adjusted to account for the 50-for-1 Outstanding Vested and not settled PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value PSUs Weighted Average Grant Date Fair Value Aggregate Intrinsic Value As of January 1, 2022 164 $ 51.50 $ 2,953 39 $ 58.81 $ 709 Granted 63 19.00 Vested and settled (39 ) 58.81 571 Cancelled/Forfeited (12 ) 57.69 As of March 31, 2022 176 (1) $ 37.85 $ 3,346 - $ - $ - (1) depending on the Company’s achievement of certain performance goals |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Disaggregation Of Revenue [Abstract] | |
Summary of information about disaggregated revenue by product mix | The following table provides information about disaggregated revenue by product mix and service (in thousands): Three Months Ended March 31, 2022 2021 Product revenue: ANNOVERA $ 8,510 $ 8,750 IMVEXXY 6,969 7,012 BIJUVA 2,560 2,445 Prescription vitamin 875 1,425 Product revenue, net 18,914 19,632 License and service 419 234 Total revenue, net $ 19,333 $ 19,866 |
Loss per common share (Tables)
Loss per common share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Summary of computation of basic and diluted loss per common share | The following table sets forth the computation of basic and diluted loss per common share (each adjusted to account for the 50 Three Months Ended March 31, 2022 2021 Numerator: Net loss $ (49,021 ) $ (39,383 ) Denominator: Weighted average common shares for basic loss per common share 8,614 6,945 Effect of dilutive securities — — Weighted average common shares for diluted loss per common share 8,614 6,945 Loss per common share, basic and diluted $ (5.69 ) $ (5.67 ) |
Schedule of antidilutive securities excluded from computation of earnings per share | The following table sets forth the outstanding securities as of the periods presented which were not included in the calculation of diluted earnings per common share during the respective three months ended March 31, 2022 and 2021 (in thousands): As of March 31, 2022 2021 Stock options 316 475 RSUs 339 147 PSUs 176 48 Warrants 103 118 934 788 |
Business Concentrations (Tables
Business Concentrations (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary of Customers with Product Revenue and Accounts Receivable | Customers with product revenue equal to or greater than 10% Three Months Ended March 31, 2022 2021 Customer A 11% 13% Customer B 18% 18% Customer C 17% 22% Customer F 14% * * Less than 10% of total product revenue |
Summary of Vendors with Product Purchases and Accounts Payable | Vendors with product purchases equal to or greater than 10% Three Months Ended March 31, 2022 2021 Catalent 28% 29% Vendor A 39% 33% Vendor B 27% 32% * Less than 10% of total product purchases |
Accounts Receivable [Member] | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary of Customers with Product Revenue and Accounts Receivable | Customers that accounted for 10% March 31, 2022 December 31, 2021 Customer B 21% 21% Customer C 34% 35% Customer D * 11% Customer F 16% * * Balance was less than 10% of accounts receivable, gross |
Accounts Payable [Member] | |
Disclosure of Revenue and Purchases [Line Items] | |
Summary of Vendors with Product Purchases and Accounts Payable | Vendors that accounted for 10% March 31, 2022 December 31, 2021 Vendor E 30% 19% Vendor F 10% 20% * Balance was less than 10% of total accounts payable |
Business, basis of presentati_3
Business, basis of presentation, new accounting standards and summary of significant accounting policies - Additional Information (Details) $ in Thousands | May 06, 2022shares | Apr. 14, 2022USD ($) | Mar. 31, 2022USD ($)shares | Mar. 31, 2021USD ($) | May 05, 2022shares | Dec. 31, 2021shares |
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ||||||
Net loss | $ 49,021 | $ 39,383 | ||||
Current liabilities over current assets | 180,400 | |||||
Total liabilities over total assets | $ 140,600 | |||||
Reverse stock split, conversion ratio | 0.02 | |||||
Reverse stock split, description | 50-for-1 reverse stock split | |||||
Number of authorized shares of common stock | shares | 12,000,000 | 12,000,000 | ||||
Forecast [Member] | ||||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ||||||
Reverse stock split, conversion ratio | 0.02 | |||||
Reverse stock split, description | shares of our common stock outstanding was split at a ratio of 50-for-1 | |||||
Number of authorized shares of common stock | shares | 12,000,000 | 600,000,000 | ||||
VitaCare Divestiture [Member] | Subsequent Event [Member] | ||||||
Basis Of Presentation And Summary Of Significant Accounting Policies [Line Items] | ||||||
Proceeds from divestiture of business | $ 150,000 | |||||
Contingent cash consideration from sale of business | 7,000 | |||||
Estimated minimum service fee commitment for remainder of fiscal year | 5,200 | |||||
Estimated minimum service fee commitment, due 2023 | 10,700 | |||||
Estimated minimum service fee commitment, due 2024 | 13,400 | |||||
Estimated minimum service fee commitment, due 2025 | 15,400 | |||||
Estimated minimum service fee commitment, due 2026 | 16,200 | |||||
Estimated minimum service fee commitment, due 2027 | $ 5,500 |
Accounts receivable - Summary O
Accounts receivable - Summary Of Accounts Receivable Allowance For Credit Losses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Receivables [Abstract] | ||
Beginning balance | $ 1,334 | |
Charges to provision for credit losses | 274 | $ 230 |
Write-off of uncollectible receivables | (274) | |
Ending Balance | $ 1,334 |
Inventory - Summary of Inventor
Inventory - Summary of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 4,394 | $ 3,042 |
Work in process | 1,231 | 1,642 |
Finished products | 3,342 | 2,938 |
Inventory | $ 8,967 | $ 7,622 |
Inventory - Additional Informat
Inventory - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Inventory Disclosure [Abstract] | ||
Inventory charge | $ 73 | $ 502 |
Prepaid and other current ass_3
Prepaid and other current assets - Schedule of prepaid and other current assets consisted of the following (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense And Other Assets Current [Abstract] | ||
Insurance | $ 1,644 | $ 2,731 |
Paragraph IV legal proceeding costs | 2,304 | 2,304 |
Other | 5,712 | 5,513 |
Prepaid and other current assets | $ 9,660 | $ 10,548 |
Fixed assets - Summary of Fixed
Fixed assets - Summary of Fixed Assets, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Fixed assets | $ 3,759 | $ 3,717 |
Less: accumulated depreciation and amortization | 2,677 | 2,518 |
Fixed assets, net | 1,082 | 1,199 |
Furniture and fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Fixed assets | 1,407 | 1,407 |
Computer and office equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Fixed assets | 1,897 | 1,855 |
Computer software [Member] | ||
Property Plant And Equipment [Line Items] | ||
Fixed assets | 375 | 375 |
Leasehold improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Fixed assets | $ 80 | $ 80 |
Fixed assets - Additional Infor
Fixed assets - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property Plant And Equipment [Abstract] | ||
Depreciation | $ 0.2 | $ 0.2 |
Licensed rights and other int_3
Licensed rights and other intangible assets - Summary of Information about License Rights and Other Intangible Assets, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross Carrying Amount | $ 48,024 | $ 47,854 |
Finite-Lived Intangible Assets, Accumulated Amortization | 8,809 | 7,868 |
Finite-Lived Intangible Assets, Net | 39,215 | 39,986 |
License Rights and Intangible Assets, Net, Gross Carrying Amount (Excluding Goodwill) | 48,356 | 48,186 |
License rights and other intangible assets, net | 39,547 | 40,318 |
License rights [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross Carrying Amount | 40,000 | 40,000 |
Finite-Lived Intangible Assets, Accumulated Amortization | 7,580 | 6,826 |
Finite-Lived Intangible Assets, Net | 32,420 | 33,174 |
Hormone therapy drug patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross Carrying Amount | 6,117 | 5,834 |
Finite-Lived Intangible Assets, Accumulated Amortization | 1,229 | 1,042 |
Finite-Lived Intangible Assets, Net | 4,888 | 4,792 |
Hormone therapy drug candidate patents - applied and pending [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Gross Carrying Amount | 1,907 | 2,020 |
Finite-Lived Intangible Assets, Net | 1,907 | 2,020 |
Trademarks/trade name rights [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Indefinite-Lived Intangible Assets, Gross Carrying Amount and Net | $ 332 | $ 332 |
Licensed rights and other int_4
Licensed rights and other intangible assets - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Patents [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | $ 0.2 | $ 0.1 |
License rights [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Amortization of intangible assets | $ 0.8 | $ 0.8 |
Accrued expenses and other cu_3
Accrued expenses and other current liabilities - Schedule of Other Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables And Accruals [Abstract] | ||
Payroll and related costs | $ 10,845 | $ 13,764 |
Rebates | 9,810 | 11,010 |
Sales returns and coupons | 1,252 | 2,422 |
Selling and marketing | 2,611 | 2,850 |
Research and development expenses | 2,295 | 1,995 |
Wholesale distributor fees | 6,352 | 3,614 |
Professional fees | 2,080 | 2,571 |
Operating lease liabilities | $ 1,369 | $ 1,361 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued expenses and other current liabilities | Accrued expenses and other current liabilities |
Other accrued expenses and current liabilities | $ 4,611 | $ 4,717 |
Accrued expenses and other current liabilities | $ 41,225 | $ 44,304 |
Accrued expenses and other cu_4
Accrued expenses and other current liabilities - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Payables And Accruals [Abstract] | ||
Advertising costs | $ 1.9 | $ 6.2 |
Debt - Schedule of Debt (Detail
Debt - Schedule of Debt (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Less: deferred financing fees | $ 22,143 | $ 11,731 |
Debt, net | 202,857 | 188,269 |
Financing Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Financing Agreement | $ 225,000 | $ 200,000 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) $ in Thousands | Apr. 14, 2022 | Mar. 31, 2022 | Mar. 31, 2022 | May 16, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | |||||
Loss on extinguishment of debt | $ 8,380 | ||||
Deferred financing fees | $ 22,143 | 22,143 | $ 11,731 | ||
VitaCare Divestiture [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from divestiture of business used to pay as prepayment on debt | $ 150,000 | ||||
Financing Agreement Amendment No 9 [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance requirement under credit agreements | 60,000 | 60,000 | |||
Prepayment penalty | 60,000 | ||||
Payment of in kind amendment fee | 30,000 | ||||
Loss on extinguishment of debt | 8,400 | ||||
Financing Agreement Amendment No 9 [Member] | Paid In Kind | |||||
Debt Instrument [Line Items] | |||||
Deferred financing fees | 30,000 | $ 30,000 | |||
Financing Agreement Amendment No 9 [Member] | VitaCare Divestiture [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Proceeds from divestiture of business used to pay as prepayment on debt | 120,000 | ||||
Debt Covenants [Member] | Financing Agreement Amendment No 9 [Member] | |||||
Debt Instrument [Line Items] | |||||
Waivable in kind amendment fee | 16,000 | ||||
Proceeds from divestiture of business used to pay as prepayment on debt | 120,000 | ||||
Debt Covenants [Member] | Financing Agreement Amendment No 9 [Member] | Minimum [Member] | |||||
Debt Instrument [Line Items] | |||||
Net proceeds from divestiture of businesses | 135,000 | ||||
Debt Covenants [Member] | Financing Agreement Amendment No 9 [Member] | Subsequent Event [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance requirement under credit agreements | $ 10,000 | ||||
Waived in kind amendment fee | $ 16,000 | ||||
Debt Covenants [Member] | Financing Agreement [Member] | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, covenant compliance | Beginning on February 7, 2022 to March 8, 2022, we did not maintain the required unrestricted cash balance of $60.0 million. In connection with Amendment No. 9, the lenders waived this event of default and reduced the required minimum unrestricted cash balance. | ||||
Debt Covenants [Member] | Financing Agreement [Member] | February 7, 2022 to March 8, 2022 [Member] | |||||
Debt Instrument [Line Items] | |||||
Minimum cash balance requirement under credit agreements | $ 60,000 | $ 60,000 |
Debt - Summary of Interest Expe
Debt - Summary of Interest Expense and Other Financing Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Debt Disclosure [Abstract] | ||
Interest expense | $ 5,364 | $ 6,455 |
Interest prepayment fees | 2,500 | |
Financing fees amortization | 9,048 | 1,272 |
Interest expense and other financing costs | $ 14,412 | $ 10,227 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Prepaid Expenses and Other Current Assets [Member] | Paragraph Four Certification Notice Letter [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Legal proceeding costs | $ 2.3 |
BIJUVA [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 50.00% |
IMVEXXY [Member] | |
Recorded Unconditional Purchase Obligation [Line Items] | |
Minimum supply commitment fee percentage payable | 60.00% |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Warrants - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Class Of Stock [Line Items] | |
Reverse stock split, conversion ratio | 0.02 |
Reverse stock split, description | 50-for-1 reverse stock split |
Warrant [Member] | |
Class Of Stock [Line Items] | |
Reverse stock split, conversion ratio | 0.02 |
Reverse stock split, description | 50-for-1 reverse stock split |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Summary of our Outstanding and Exercisable Warrants and Related Transactions (Details) - Warrant [Member] - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Class Of Warrant Or Right [Line Items] | ||
Beginning balance, Warrants | 103,000 | |
Ending balance, Warrants | 103,000 | 103,000 |
Beginning balance, Weighted Average Exercise Price | $ 76.19 | |
Ending balance, Weighted Average Exercise Price | $ 76.19 | $ 76.19 |
Warrants, Weighted Average Remaining Contractual Life (in Years) | 8 years 1 month 6 days | 8 years 3 months 18 days |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Share-based Compensation Payment Plans - Additional Information (Details) $ in Millions | 3 Months Ended | |
Mar. 31, 2022USD ($)shares | Mar. 31, 2021USD ($) | |
Class Of Stock [Line Items] | ||
Number of shares outstanding | 963,584 | |
Reverse stock split, conversion ratio | 0.02 | |
Reverse stock split, description | 50-for-1 reverse stock split | |
Share-based payment arrangement, expense | $ | $ 2.1 | $ 3 |
Total unrecognized share based compensation | $ | $ 17.8 | |
Share-based compensation over a weighted average period | 2 years 2 months 12 days | |
2019 Stock Incentive Plan [Member] | ||
Class Of Stock [Line Items] | ||
Number of shares common stock available | 83,880 | |
Performance Shares Unit [Member] | ||
Class Of Stock [Line Items] | ||
Number of shares outstanding | 831,066 | |
Options [Member] | ||
Class Of Stock [Line Items] | ||
Reverse stock split, conversion ratio | 0.02 | |
Reverse stock split, description | 50-for-1 reverse stock split | |
RSU Outstanding [Member] | ||
Class Of Stock [Line Items] | ||
Reverse stock split, conversion ratio | 0.02 | |
Reverse stock split, description | 50-for-1 reverse stock split | |
PSUs Outstanding [Member] | ||
Class Of Stock [Line Items] | ||
Reverse stock split, conversion ratio | 0.02 | |
Reverse stock split, description | 50-for-1 reverse stock split |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) - Summary of Stock Option Activity (Details) - $ / shares shares in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Equity [Abstract] | ||
Options awards outstanding, Beginning balance | 353 | |
Options awards outstanding, Cancelled/Forfeited | (37) | |
Options awards outstanding, Ending balance | 316 | 353 |
Options awards outstanding, weighted average exercise price, Beginning balance | $ 225.97 | |
Options awards outstanding, weighted average exercise price, Cancelled/Forfeited | 161.72 | |
Options awards outstanding, weighted average exercise price, Expired | 175.77 | |
Options awards outstanding, weighted average exercise price, Ending balance | $ 231.87 | $ 225.97 |
Options awards outstanding, Weighted Average Remaining Contractual Life (in Years) | 3 years 8 months 12 days | 3 years 9 months 18 days |
Options awards exercisable, Option Awards | 300 | 336 |
Options awards exercisable, Weighted Average Exercise Price | $ 237.58 | $ 230.93 |
Options awards exercisable, Weighted Average Remaining Contractual Life (in Years) | 3 years 7 months 6 days | 3 years 7 months 6 days |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) - Schedule of Restricted Stock Units (Details) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($)$ / sharesshares | |
RSU Outstanding [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance, number of shares | shares | 272 |
Granted, number of shares | shares | 106 |
Vested/Released, number of shares | shares | (32) |
Forfeited, number of shares | shares | (7) |
Ending balance, number of shares | shares | 339 |
Beginning balance, weighted average grant date fair value | $ / shares | $ 58.17 |
Granted, weighted average grant date fair value | $ / shares | 21.70 |
Vested/Released, weighted average grant date fair value | $ / shares | 105.28 |
Forfeited, weighted average grant date fair value | $ / shares | 53.74 |
Ending balance, weighted average grant date fair value | $ / shares | $ 43.11 |
Beginning balance, aggregate intrinsic value | $ | $ 4,890 |
Aggregate intrinsic value, vested/released | $ | 469 |
Ending balance, aggregate intrinsic value | $ | $ 6,440 |
RSU Vested and Not Settled [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Beginning balance, number of shares | shares | 31 |
Ending balance, number of shares | shares | 13 |
Beginning balance, weighted average grant date fair value | $ / shares | $ 105.28 |
Ending balance, weighted average grant date fair value | $ / shares | $ 74.17 |
Beginning balance, aggregate intrinsic value | $ | $ 566 |
Ending balance, aggregate intrinsic value | $ | $ 252 |
Stockholders' Equity (Deficit_7
Stockholders' Equity (Deficit) - Schedule of Performance Stock Units (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Dec. 31, 2021 | ||
PSUs Outstanding [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Beginning balance, number of shares | 164 | ||
Granted, number of shares | 63 | ||
Vested and settled, number of shares | (39) | ||
Forfeited, number of shares | (12) | ||
Ending balance, number of shares | [1] | 176 | |
Beginning balance, weighted average grant date fair value | $ 51.50 | ||
Granted, weighted average grant date fair value | 19 | ||
Vested/Released, weighted average grant date fair value | 58.81 | ||
Forfeited, weighted average grant date fair value | 57.69 | ||
Ending balance, weighted average grant date fair value | $ 37.85 | ||
Aggregate intrinsic value | $ 3,346 | $ 2,953 | |
Aggregate intrinsic value, vested/released | $ 571 | ||
PSUs Vested and Not Settled [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Beginning balance, number of shares | 39 | ||
Beginning balance, weighted average grant date fair value | $ 58.81 | ||
Aggregate intrinsic value | $ 709 | ||
[1] | The number of PSUs represents the base number of PSUs that may vest. The actual number of PSUs that will vest will be between zero and 308,630 depending on the Company’s achievement of certain performance goals |
Stockholders' Equity (Deficit_8
Stockholders' Equity (Deficit) - Schedule of Performance Stock Units (Parenthetical) (Details) - Performance Shares Unit [Member] | Mar. 31, 2022shares |
Minimum [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares expected to vest | 0 |
Maximum [Member] | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Number of shares expected to vest | 308,630 |
Stockholders' Equity (Deficit_9
Stockholders' Equity (Deficit) - Summary of Unrecognized Share Based Compensation Cost Expected to be Recognized (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Equity [Abstract] | |
2022 (9 months) | $ 8,124 |
2023 | 5,838 |
2024 | 3,513 |
2025 | 368 |
Total | $ 17,843 |
Revenue - Summary of informatio
Revenue - Summary of information about disaggregated revenue by product mix (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 19,333 | $ 19,866 |
ANNOVERA [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | 8,510 | 8,750 |
IMVEXXY [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | 6,969 | 7,012 |
BIJUVA [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | 2,560 | 2,445 |
Prescription Vitamins [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | 875 | 1,425 |
Product [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | 18,914 | 19,632 |
License and Service [Member] | ||
Product revenue: | ||
Revenue from Contract with Customer, Including Assessed Tax | $ 419 | $ 234 |
Revenue - Additional Informatio
Revenue - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue [Line Items] | ||
Sales | $ 19,333,000 | $ 19,866,000 |
BIJUVA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Sales | 2,560,000 | 2,445,000 |
IMVEXXY [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Sales | 6,969,000 | $ 7,012,000 |
Theramex License Agreement [Member] | BIJUVA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Sales | 700,000 | |
Knight License Agreement [Member] | BIJUVA [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Sales | 0 | |
Theramex and Knight License Agreement [Member[ | IMVEXXY [Member] | ||
Disaggregation of Revenue [Line Items] | ||
Sales | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Tax Disclosure [Abstract] | ||
Provision for income taxes | $ 0 | $ 0 |
Loss per common share - Additio
Loss per common share - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Reverse stock split, conversion ratio | 0.02 |
Reverse stock split, description | 50-for-1 reverse stock split |
Loss per common share - Summary
Loss per common share - Summary of computation of basic and diluted loss per common share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net loss | $ (49,021) | $ (39,383) |
Denominator: | ||
Weighted average common shares for basic loss per common share | 8,614 | 6,945 |
Effect of dilutive securities | 0 | 0 |
Weighted average common shares for diluted loss per common share | 8,614 | 6,945 |
Loss per common share, basic and diluted | $ (5.69) | $ (5.67) |
Loss per common share - Schedul
Loss per common share - Schedule of calculation of diluted net loss per share allocable to common stockholders (Details) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 934 | 788 |
Stock options [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 316 | 475 |
RSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 339 | 147 |
PSUs [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 176 | 48 |
Warrant [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 103 | 118 |
Related parties - Additional In
Related parties - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Catalent [Member] | |
Related Party Transaction [Line Items] | |
Amount billed | $ 800,000 |
American International Group [Member] | Maximum [Member] | |
Related Party Transaction [Line Items] | |
Amount billed | $ 100,000 |
Business concentrations - Addit
Business concentrations - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Customer Concentration Risk [Member] | Maximum [Member] | Accounts Receivable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Customer Concentration Risk [Member] | Maximum [Member] | Revenue [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Customer Concentration Risk [Member] | Minimum [Member] | Accounts Receivable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Customer Concentration Risk [Member] | Minimum [Member] | Revenue [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Vendor Concentration Risk [Member] | Maximum [Member] | Product purchases [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Vendor Concentration Risk [Member] | Maximum [Member] | Accounts Payable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Vendor Concentration Risk [Member] | Minimum [Member] | Product purchases [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Vendor Concentration Risk [Member] | Minimum [Member] | Accounts Payable [Member] | |
Concentration Risk [Line Items] | |
Concentration Risk, Percentage | 10.00% |
Business concentrations - Summa
Business concentrations - Summary of Customers with Product Revenue (Details) - Customer Concentration Risk [Member] - Revenue [Member] | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Customer A [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 11.00% | 13.00% |
Customer B [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 18.00% | 18.00% |
Customer C [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 17.00% | 22.00% |
Customer F [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 14.00% |
Business concentrations - Sum_2
Business concentrations - Summary of Customers that Accounted for 10% or Greater of Accounts Receivable (Details) - Customer Concentration Risk [Member] - Accounts Receivable [Member] | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Customer B [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 21.00% | 21.00% |
Customer C [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 34.00% | 35.00% |
Customer F [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 16.00% | |
Customer D [Member] | ||
Disclosure Of Customers With Product Revenue and Account Receivable For The Period [Line Items] | ||
Concentration Risk, Percentage | 11.00% |
Business concentrations - Sum_3
Business concentrations - Summary of Vendors with Product Purchases (Details) - Product purchases [Member] - Vendor Concentration Risk [Member] | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Catalent [Member] | ||
Disclosure Of Vendors With Product Purchases And Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 28.00% | 29.00% |
Vendor A [Member] | ||
Disclosure Of Vendors With Product Purchases And Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 39.00% | 33.00% |
Vendor B [Member] | ||
Disclosure Of Vendors With Product Purchases And Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 27.00% | 32.00% |
Business concentrations - Sum_4
Business concentrations - Summary of Vendors Accounted for 10% or Greater of Accounts Payable (Details) - Vendor Concentration Risk [Member] - Accounts Payable [Member] | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2020 | |
Vendor E [Member] | ||
Disclosure Of Vendors With Product Purchases And Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 30.00% | 19.00% |
Vendor F [Member] | ||
Disclosure Of Vendors With Product Purchases And Accounts Payable For The Periods [Line Items] | ||
Concentration Risk, Percentage | 10.00% | 20.00% |